Field of the Invention
The present invention relates to a novel pharmaceutical composition for treating and saving the wounded, and to a method for the preparation thereof.
Nowadays blood transfusion and fluid infusion are the important measures to treat and save the wounded, especially the traumatic shock. Usually, the principle of transfusion is “to infuse component the patient is deficient in, to supply how much the patient needs”. For example, when the patient mainly lost his blood, he should be transfused with blood, even though sometimes the patient needs to be transfused with blood from normal individuals. When the patient mainly lost plasma, plasma or plasma volume expander should be transfused to him; when the patient mainly lost intercellular fluid, physiological saline should be infused. In fact, the treating and saving measures of formulating physiological solutions on the basis of normal composition of body, or transfusing with blood from normal individuals to the patient with evident physiopathological changes is to treat the organism as mechanical device, therefore these measures often have following disadvantages:
(1) Blood transfusion: In general, the volume of blood transfusion closes to or exceeds the volume of blood lost. If a big amount of blood is required, the blood source will be difficult, the cost is expensive. The preparation and storage need certain conditions. In addition, before transfusion, some time should be taken for blood typing and cross match tests, and only the substitutes could be used for the individuals with rare blood types. Blood transfusion could result in production of anti-platelet antibodies and anti-leucocyte antibodies, as well as various hematogenic infectious diseases, for example, AIDS, hepatitis B, hepatitis C. etc.
(2) Albumin infusion: There is a great demand, a great expense difficult source, complicated preparation method and certain requirements for, the method storage. After albumin infusion, it could effuse through capillaries, and couldn't be reabsorbed into vessel. Therefore interstitial edema will occur, and might result in pulmonary edema, renal failure, and cardiac insufficiency, by contrast enhance the mortality. Albumin infusion could result in evident decrease of α1, α2, β, γ-globulins and fibrinogen, cause reduction of immunity, and affect function of blood coagulation.
(3) Infusion of fluorocarbon as plasma substitute: It requires a large amount of the substitute and simultaneous inhalation of oxygen with high component pressure. Otherwise the demand of the organism is not met. The fluorocarbon as plasma substitute should be preserved in low temperature, and its transport is not convenient. For example, thirty minutes before infusion the patient should be injected with 10 mg of dexamethasone. The frozen injection for infusion should be thawed. Thus, the procedures are complicated. After infusion, the observation should be continued for 5-10 min. The infusion of fluorocarbon as plasma substitute could induce adverse reactions, such as anaphylaxis, hypotension, thrombocytopenia, hepatosplenomegaly, reduction of immunity, and abnormality of fibrinolysis system.
(4) Infusion of balanced buffers, its amount infused should be three times more than the volume of blood lost to maintain the blood pressure. 60-80% the solution infused could effuse out of the blood vessel, which results in tissue edema (for example, cerebral edema, pulmonary edema) and renal insufficiency, it could cause the difficulty for sequential therapy.
(5) Infusion of physiological saline. Its amount infused should also be three times more than the volume of blood lost. Its efficacy is poorer than balanced buffers, and its adverse effects are more significant.
To solve the problems in blood transfusion and infusion, the skilled in the art had studied anti-shock therapy with hypertonic sodium chloride solution. For example, 7.5% (w/v) NaCl solution suggested by Velasco. But the hypertonic NaCl solution has some toxicity to the organism.
Most investigators have proposed intravenous injection of hypertonic NaCl solution for anti-shock therapy, but it usually leads to obvious complications, such as hypotension, rupture of blood cells induced by extra hypertonic solution, cardiac insufficiency, decreased renal function and disorders of nervous system.
Thus, it can be showed that there is a demand for novel anti-shock drugs to reverse the physiopathological condition of shock, in order to obtain time for sequential therapy after the emergency treatment, and to create opportunity with improved effect of treating and saving the wounded and patients, and with increased survival rate.